DOCUMENT: Scope of Practice
CLASSIFICATION: Position Paper
STATUS: Approved — ASCLS House of Delegates, August 2, 2001
The current healthcare environment is one of considerable uncertainty, unprecedented change and limitless potential. The human genome project, and other efforts in medical research, provides us with great expectations for scientific and clinical breakthroughs in the detection, treatment and prevention of disease. Although there is great promise, the continuing changes in health care delivery and financing will have a profound impact on the availability and utilization of both new and existing diagnostic services.
Due to this dynamic scientific, economic and regulatory environment, expanded roles for non-physician healthcare professionals, including clinical laboratory scientists, will allow the important issues of cost containment, access, quality and appropriateness to be more effectively addressed. While the costs of healthcare continue to rise, there are significantly raised expectations from physicians and healthcare consumers to deliver information in a manner, which will facilitate rapid diagnosis and treatment.
At a time when the cost of healthcare is over 14% of the country’s gross national product, clinical laboratory services continue to provide a significant level of value, contributing up to 70% of the objective information used to make diagnostic decisions, while comprising only 5% of a typical hospital budget.1 It is timely to advance the independent and collaborative roles of the clinical laboratory scientist in providing efficient and effective healthcare. It is time for the most suitable healthcare professionals to provide the most appropriate level of care. Ultimately, by having each specific healthcare profession play their most appropriate role, the total care provided for the consumer will be superior and unnecessary invasive procedures will be avoided. Resources will be more effectively utilized and expertise valued for the contributions made.
Maximizing the effective delivery of the components of health care, in today’s complex delivery system, will help address the rapidly escalating cost of health care and the issues of access to quality and affordable care. The most appropriate care by the most appropriate healthcare professional is the ultimate answer to the current health care dilemma.
In previous statements of opinion, policy and positions, the American Society for Clinical Laboratory Science (ASCLS) has established that clinical laboratory science is a profession: (a) distinct from the practice of medicine; (b) characterized by its own, internally-defined Body of Knowledge and Scope of Practice; (c) which certifies its own practitioners and (d) requires of its practitioners competency in scientific, technical, managerial and scholarly principles, and high standards of performance and professional conduct.
ASCLS defines the profession of clinical laboratory science as encompassing the design, performance, evaluation, reporting, interpreting and clinical correlation of clinical laboratory testing and the management of all aspects of these services. Clinical laboratory tests are utilized for the purpose of diagnosis, treatment monitoring and prevention of disease. The profession includes generalists as well as individuals qualified in a number of specialized areas of expertise including microbiology/virology, hematology, immunology, transfusion medicine, clinical chemistry, endocrinology, toxicology, cytogenetics and molecular diagnostics. Integral features of each of the specialties may include research, consultation, education, information management, marketing and administration. The profession has a code of ethics that sets forth the principles and standards by which clinical laboratory professionals practice.
Clinical laboratory personnel, as members of the health care delivery team, are responsible for assuring reliable and accurate laboratory test results which contribute to the diagnosis, treatment, prognosis, and prevention of physiological and pathological conditions in humans.
Quality clinical laboratory testing is evidenced by: performing the correct test, on the right person, at the right time, producing accurate test results, with the best outcome, in the most cost-effective manner. This is accomplished by:
The practice of clinical laboratory science requires:
The following scenarios describe specific examples of the scope of practice of clinical laboratory science.
Providers of Clinical Laboratory Services, Upon Either Physician or Consumer Request, in Facilities, which may be Owned or Operated by Clinical Laboratory Scientists
Within the scope of practice governing the profession, and consistent with ethical and legal considerations, clinical laboratory scientists, qualified by education and experience, perform laboratory tests and provide test results to physicians and to consumers upon request or upon physician referral, in laboratories which clinical laboratory scientists may own or operate. Clinical laboratory scientists exercise prudence and judgment to ensure that such services are consistent with good practice and sound professional ethics.
Directors of Full-Service Clinical Laboratories
Non-physician clinical laboratory scientists, with appropriate graduate education, direct full-service clinical laboratories. This function is firmly grounded in (a) applicable state law, and (b) federal regulations governing clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 and laboratory participation in Medicare and Medicaid.
Consultants for Clinical Laboratory Services
Clinical laboratory scientists may appropriately provide technical assistance to physicians, manufacturers, and consumers of clinical laboratory testing services, including: advising upon the design and service scope of clinical laboratories; advising physicians in the appropriate utilization, selection and sequencing of clinical laboratory tests and, in collaboration with attending physicians, determining clinical correlations and interpretations of the quality and utility of specific laboratory results; advising manufacturers upon the design and development of clinical laboratory instruments, test kits and other components; and advising other users and consumers of clinical laboratory testing services upon appropriate use, maintenance, quality assurance and other procedural and informational requirements.
Providers of Disease-State Risk and Wellness Assessments
Clinical laboratory science is distinct from the practice of medicine, which renders diagnosis and provides treatment for human beings. While clinical laboratory scientists provide critical information, they do not diagnose or prescribe treatment. They qualify by education and experience to perform screening tests to identify the presence or absence of factors known to be associated with risk of disease or impairment. Such services may include but are not limited to performing and reporting to consumers the results of tests to determine blood cholesterol levels and the presence or absence of metabolized substances of abuse. In all such cases, clinical laboratory scientists are bound by applicable laws and regulations, as well as by standards of good practice and sound professional ethics, in their relationships with consumers and with practitioners of medicine.
For each of three functions of clinical laboratory science practice — scientific, managerial and educational — there are hierarchical levels of practice, based upon education and experience. Specific knowledge and experience are required for each level of practice within the three functions. As more experience and education is earned, an individual is eligible, after demonstrating competence to practice at that level. Certain knowledge and experience is common to all three functions; none is mutually exclusive of the others. Demands of the health care environment often require an individual to provide more than one function, thereby performing at different levels of practice.
The scientific function includes the production of test data, monitoring the accuracy, precision and utility of laboratory testing, the correlation and interpretation of test data, and the design, evaluation and implementation of new laboratory test methods.
The managerial function includes managing all aspects — technical, fiscal, workflow, and human resources — of laboratory operations.
The educational function includes the establishment and management of educational programs for new and current clinical laboratory practitioners, other healthcare providers and consumers.
The American Society for Clinical Laboratory Science believes that personnel standards should be prescribed for ALL personnel including directors, supervisors, clinical laboratory scientists and other laboratory technical personnel to insure the accuracy and reliability of test performance.
ASCLS supports the concept of the regulatory complexity model and believes that personnel standards at the technical levels must be defined in terms of qualifications needed to perform testing at CLIA defined complexity levels.
ASCLS supports utilization of validated competency-based credentialling examinations for all laboratory practitioners performing moderate and high complexity testing. Waived testing should be performed by properly trained personnel. A certified clinical laboratory scientist should conduct this training.
ASCLS supports the use of benchmarks to more succinctly typify positions at various levels of work and different types of work presently performed by practitioners in the clinical laboratory. A benchmark is defined as something that serves as the standard by which others may be measured.
ASCLS supports the concept of equivalent routes for the Clinical Laboratory Scientist only in combination with a baccalaureate degree as defined by the National Credentialing Agency for Clinical Laboratory Personnel.2
ASCLS supports the concept of equivalent routes for the Clinical Laboratory Technician only in combination with an associate degree as defined by the National Credentialing Agency for Clinical Laboratory Personnel.2
Experience requirements for these equivalent routes incorporating "full-time clinical laboratory experience" for equivalency must include ALL major disciplines typically required in the clinical component of a clinical laboratory science education program accredited by an agency recognized by the U.S. Department of Education. Such experience shall be under the supervision of a certified clinical laboratory scientist in a CLIA certified laboratory.
ASCLS supports the concept of career mobility (ladder) which includes utilization of validated competency-based credentialing examinations to determine competency of personnel at all levels of responsibility.
ASCLS believes that all practitioners should demonstrate continued competence through recertification.
The current economic and regulatory healthcare environment benefits from the roles described for clinical laboratory scientists in order to achieve high quality, cost-effective assessment, diagnosis, treatment, and prevention to meet the needs of a changing healthcare consumer.
1Clinical Chemistry, 1996, 42: (5): 813-816.
2National Credentialing Agency for Clinical
Laboratory Personnel, Eligibility Routes, 1995.